Fluorobenzene

Neurotoxicity

Administrative data

Endpoint:

neurotoxicity: short-term inhalation

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Reference 2

Reference Type:

publication

Title:

Toxicological Evaluations Vol. 13

Author:

BG Chemie

Year:

1998

Bibliographic source:

Springer-Verlag Berlin Heidelberg, ISBN 3-540-62658-1

Reference 3

Reference Type:

study report

Title:

Unnamed

Year:

1993

Reference 4

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)

Principles of method if other than guideline:

The TS was administered by nose only inhalation to three groups, each of five male and five female rats for 28 consecutive days at target concentrations of 0.4, 1.5 and 6.0 mg/L. A control group was exposed to air only.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fluorobenzene

EC Number:

207-321-7

EC Name:

Fluorobenzene

Cas Number:

462-06-6

Molecular formula:

C6H5F

IUPAC Name:

fluorobenzene

Details on test material:

- Purity > 99.9%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: males: 168-212 g; females: 136-188 g

Administration / exposure

Route of administration:

inhalation

Vehicle:

other: air

Details on exposure:

Nose-only inhalation

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Gas chromatography

Duration of treatment / exposure:

28 days, 6 hours/day

Frequency of treatment:

daily

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0.4 mg/L air (nominal)

Remarks:

equals 0.37 mg/L analytical concentration

Doses / concentrations 2

Dose / conc.:

1.5 mg/L air (nominal)

Remarks:

equals 1.50 mg/L analytical concentration

Doses / concentrations 3

Dose / conc.:

6 mg/L air (nominal)

Remarks:

equals 6.24 mg/L analytical concentration

No. of animals per sex per dose:

5

Control animals:

yes, sham-exposed

Examinations

Observations and clinical examinations performed and frequency:

Clinical signs, bodyweight, food and water consumptions were monitored during the study together with specific neurotoxicity functional observations. Haematology, blood chemistry and urinalysis were evaluated for all animals at the end of the study.

Neurobehavioural examinations performed and frequency:

The rats underwent a detailed neurological examination on days 13 and 27 (males) or days 14 and 28 (females) of the study. The criteria examined
included behavioural, functional, motor and sensory disturbances and reflex behaviour (25 parameters in total).

Sacrifice and (histo)pathology:

All animals were subjected to a gross necropsy examination and fluoride analysis was subsequently carried out on pooled samples of sternum bone and teeth. Limited histopathological evaluation of tissues was performed on all animals from all groups.

Results and discussion

Effect levels

Dose descriptor:

NOAEC

Effect level:

0.37 mg/L air

Based on:

test mat.

Sex:

male/female

Basis for effect level:

histopathology: non-neoplastic

Any other information on results incl. tables

No signs of fluorobenzene having neurotoxic activity could be detected.

Applicant's summary and conclusion

Conclusions:

No signs of fluorobenzene having neurotoxic activity could be detected.